Devices

Device Recall CVI (Cardiovascular Innovations)

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: XX-02-X; XXX-03-X; XXX-04-X; XXX-05-X; 356-05; 356-06; 360-06; 361-06; 024-07; 044-07; 045-07; 046-07, where X is any number.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide, including USA, Canada, Netherlands, and Germany.
  • 제품 설명
    CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)
  • Manufacturer
    Lemaitre Vascular, Inc.
  • 1 Event

제조사

Lemaitre Vascular, Inc.
  • 제조사 주소
    Lemaitre Vascular, Inc., 63 Second Avenue, Burlington MA 01803-4413
  • Source
    USFDA